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Manager, Product Lifecycle Engineering

terumobct

📅 20/08/2026
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Requisition ID: [[id]] At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours. As the Manager, Product Lifecycle Engineering , you will play a key leadership role in advancing our medical device portfolio by optimizing product lifecycle processes and enabling the delivery of high-quality, patient-focused solutions. As part of the Product Lifecycle Excellence Team, you'll leverage your expertise in Windchill and engineering best practices to lead complex initiatives, solve challenging technical problems, and implement process improvements that support the entire product lifecycle. Reporting into Quality, you will collaborate with cross-functional teams to shape the future of life-saving technologies while influencing strategic projects with global impact. This is an exceptional opportunity for an innovative leader who thrives in a dynamic environment and is excited to make meaningful contributions to the next generation of medical devices. ESSENTIAL DUTIES Product Lifecycle Management (PLM): Oversee and manage all aspects of product data throughout its lifecycle using Windchill, ensuring compliance with industry regulations. Develops new processes that have a significant impact on multiple disciplines. Contributes to the establishment of business objectives, goals, budgets and costs as requested. Regulatory Compliance: Ensure that all documentation and processes meet regulatory requirements such as FDA, ISO 13485, and other relevant global standards. Data Integrity and Security: Maintain high levels of data integrity and security within Windchill, ensuring that sensitive information is protected in accordance with industry regulations. Configuration Management: Manage product configuration and change control processes to ensure accuracy and consistency across all stages of product development. Collaboration Facilitation: Support cross-functional teams by facilitating collaboration through efficient use of Windchill, enhancing communication between engineering, quality assurance, manufacturing, and regulatory affairs departments. Presents complex technical information/analysis, and responds to questions from technical staff members and management regularly and effectively. Provides broad-based direction for subordinates and colleagues within functional area and cross functionally. Program Management: Guides the successful completion of major programs and may function in a project leadership role. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives. Keeps updated on recent technical advances within the industry and applies this knowledge to products and processes. Engineering: Directs one or more major phases of complex engineering work, utilizing engineering skills to devise entirely new approaches to problems encountered in projects. Training and Support : Provide training sessions for staff on best practices in using Windchill effectively while offering ongoing support to troubleshoot issues as they arise. Mentors less experienced engineers. Process Improvement: Continuously assess current PLM processes within Windchill to identify opportunities for improvement that align with both business objectives and compliance requirements. Documentation Management: Ensure comprehensive documentation management within Windchill for all project phases from design through post-market activities. Audit Preparation: Assist in preparing for internal and external audits by ensuring all necessary documentation is accurate, complete, and readily available within Windchill. Reporting and Analysis: Generate detailed reports on product data management activities to provide insights into process efficiencies or bottlenecks requiring attention. Works on complex issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Work direction responsibility may include technicians and junior engineers. May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues. May contribute to the establishment of business objectives, goals, budgets and costs. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree in engineering or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience Minimum 8 years experience. Two years of GMP manufacturing experience required. Skills Windchill Proficiency: Extensive experience in utilizing Windchill PLM software for product lifecycle management, including version control, change management, and document control. Regulatory Compliance: Strong understanding of regulatory requirements specific to the medical device industry (e.g., FDA regulations, ISO standards), ensuring all documentation and processes adhere to these stringent guidelines. Product Lifecycle Management (PLM): Proven ability to manage and optimize product data throughout its lifecycle, from conception through design, manufacturing, service, and disposal. Technical Proficiency/Documentation: Knowledge and use of relevant PC software applications, with skills to use them effectively. Expertise in creating and maintaining technical documents such as design specifications, validation protocols, and SOPs within the Windchill environment. Problem-Solving Skills: Ability to troubleshoot PLM-related issues effectively and implement solutions that enhance system performance and user experience. Collaboration Skills: Experience working cross-functionally with engineering teams, quality assurance departments, regulatory affairs professionals, and other stakeholders to ensure seamless integration of PLM processes. Training & Support: Capability to train team members on Windchill functionalities and provide ongoing support to ensure optimal usage of the system across departments. Attention to Detail: Keen eye for detail necessary for maintaining accuracy in documentation critical for compliance with medical device regulations. Project Management: Experience managing projects related to system upgrades or process improvements within a PLM environment is a plus. Leadership and Collaboration: Driver for acquiring resources and building consensus across products. Solicits and accepts the ideas of others, fostering an environment conducive to open communication. Communication: Demonstrated ability to communicate effectively both verbally and in writing. Regularly presents complex technical information/analysis clearly and responds to questions from technical staff members and management. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. LOCATION Lakewood, Colorado - Onsite (hybrid) - Open to candidates willing to relocate to the area. PHYSICAL R
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